ProKidney — Third Quarter 2026 Earnings Summary

Financial Performance:

• Revenue for the three months ended September 30, 2026, was $174,000, compared to $217,000 in the same period in 2025.
• Revenue for the nine months ended September 30, 2026, was $550,000, compared to $668,000 in the same period in 2025.
• Research and development expenses were $40.8 million for the three months ended September 30, 2026, an increase of $14.0 million from $26.8 million in the prior year period.
• General and administrative expenses were $13.1 million for the three months ended September 30, 2026, an increase of $1.2 million from $11.9 million in the prior year period.
• Net loss before noncontrolling interest was $51.8 million for the three months ended September 30, 2026, compared to $35.8 million in the same period in 2025.
• Net loss attributable to Class A common stockholders was $35.6 million for the three months ended September 30, 2026, compared to $16.5 million in the prior year period.
• Net loss per share (basic and diluted) was $0.17 for the three months ended September 30, 2026, compared to $0.12 in the prior year period.
• Cash, cash equivalents, and marketable securities totaled $141.9 million as of September 30, 2026, down from $181.6 million as of June 30, 2026.
• Total assets were $210.3 million as of September 30, 2026, compared to $335.6 million as of December 31, 2025.
• Total liabilities were $33.3 million as of September 30, 2026, compared to $34.8 million as of December 31, 2025.
• Redeemable noncontrolling interest was $1,083.8 million as of September 30, 2026, compared to $1,312.0 million as of December 31, 2025.
• Net cash flows used in operating activities were $120.7 million for the nine months ended September 30, 2026, compared to $87.6 million in the prior year period.

Guidance and Future Outlook:

• The company is on track to deliver pivotal Phase 3 PROACT 1 surrogate endpoint (eGFR slope) topline results in the second quarter of 2027.
• Full enrollment for the PROACT 1 confirmatory analysis is anticipated in the first quarter of 2027 with over 500 patients.
• The confirmatory endpoint (composite time-to-event) topline readout for PROACT 1 is expected in the second half of 2029.
• Current cash, cash equivalents, and marketable securities are expected to support operating plans into mid-2027.
• The efficacy analysis set for the PROACT 1 topline readout is expected to include approximately 320 patients.

Business Segments and Product Lines:

• The company is advancing its lead product candidate, rilparencel (REACT®), a first-in-class autologous cell therapy for Stage 3b/4 CKD and type 2 diabetes.
• The Phase 3 REGEN-006 (PROACT 1) study is a randomized, blinded, sham-controlled safety and efficacy study focusing on patients with Stage 4 CKD and late Stage 3b CKD.
• The study protocol was amended in the first half of 2024 to focus on a specific subset of patients with accompanying albuminuria.
• Eight abstracts were presented at ASN Kidney Week 2026, including seven spanning CKD translational models and drug product characterization, and one pooled Phase 2 clinical analysis.
• A virtual KOL event was hosted following ASN Kidney Week to discuss mechanism of action findings and rilparencel's potential role in advanced CKD and type 2 diabetes.

Market and Competitive Landscape:

• CKD affects an estimated 37 million adults in the U.S., with diabetes being the leading cause.
• The target population for rilparencel includes over one million people in the U.S. with Stage 3b/4 CKD and type 2 diabetes.
• There remains a substantial unmet need for therapies that can stabilize kidney function and delay or prevent the need for dialysis in patients with advanced CKD.
• Current treatment options aim to slow disease progression, but there is a need for therapies that can stabilize kidney function.

Risks and Challenges:

• Risks include the inability to maintain the listing of Class A common stock on Nasdaq and potential exclusion from various indices.
• There is a risk that clinical trial results may not support approval or that the FDA could require additional studies.
• The company faces risks associated with the need for additional financing and the inability to raise capital in the future.
• Uncertainties exist regarding regulatory clearance, intellectual property rights, and the ability to compete with other companies in the biologics and kidney disease treatment markets.
• Risks include disruptions to the business from domestication to the United States and the impact of geopolitical conflict.
• The company's actual results may differ from expectations due to uncertainties inherent in cell therapy research and development.

Management Commentary and Tone:

• CEO Bruce Culleton, M.D., stated that the third quarter marked continued progress with PROACT 1 advancing toward full enrollment and the pivotal eGFR slope topline readout remaining on track for Q2 2027.
• Management noted that data presented at Kidney Week strengthens the mechanistic and clinical evidence supporting rilparencel and provides a cohesive picture of its potential to stabilize kidney function.
• Management expressed confidence as they approach the important Phase 3 readout and continue their mission to transform the treatment of advanced CKD.

Other Key Points:

• Patient recruitment for the PROACT 1 study was accelerated in mid-2026, increasing the anticipated full enrollment from 470 to over 500 patients.
• R&D expense increases were driven by clinical study and related manufacturing costs ($7.4 million), professional fees ($1.3 million), operational costs ($3.5 million), and compensation costs ($1.8 million).
• G&A expense increases were primarily driven by compensation costs ($1.7 million) related to hiring additional personnel, partially offset by decreases in professional fees and impairment charges.
• Shares outstanding (Class A and Class B common stock) totaled 302,371,200 as of September 30, 2026.
• The company is a pioneer in the treatment of CKD through innovations in cell therapy, founded in 2015 after a decade of research.
• The Phase 3 study involves randomization (1:1) to treatment or sham control groups prior to kidney biopsy or a sham biopsy procedure.
• The primary objective is to assess the efficacy of up to two rilparencel injections using a minimally invasive percutaneous approach.
• The surrogate endpoint for accelerated approval is eGFR slope, while the primary composite endpoint is the time from first injection to the earliest of: at least 40% reduction in eGFR; eGFR <15 mL/min/1.73m²; chronic dialysis; renal transplant; or renal or cardiovascular death.